Repairing a deep donor site using a new, dissolvable, plastic scaffold.

An evaluation of function and appearance following reconstruction of a free-flap donor site after biodegradable polymer implant incorporation and secondary split skin grafting.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000753954

Enrollment

Registered

2011-07-18

Start date

2012-08-29

Completion date

2013-07-28

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Single group study of efficacy in improving free flap donor sites by first integrating a biodegradable polyurethane dermal matrix before skin grafting.

Interventions

Following free-flap harvest (either anterolateral thigh flap or radial forearm flap), a biodegradable polyurethane dermal matrix sealed with a non-biodegradable polyurethane film will be implanted into the donor site. When integrated, the film is removed and a thin split skin graft applied to the integrated neo-dermis.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Ability to provide informed consent; requirement for free-flap surgery involving either anterolateral thigh flap or radial forearm flapfree

Exclusion criteria

Pregnancy, severe debility precluding second anaesthetic; inability to provide informed consent

Outcome results